Admelog (insulin lispro biosimilar) / Sanofi - LARVOL DELTA

Afrezza® INHALE-1 Study in Pediatrics (clinicaltrials.gov) - P3 | N=319 | Completed | Sponsor: Mannkind Corporation | Active, not recruiting ➔ Completed

Trial completion • Diabetes • Metabolic Disorders • Pediatrics • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus

What do the guidelines say about use of biosimilar insulin therapy? Simple practical considerations to guide clinicians in different patient subgroups-Sharing Canadian perspectives. (PubMed, Diabetes Obes Metab) - "This review article intends to review the efficacy and safety data from pivotal clinical trials with biosimilar insulins, as well as the regulatory and health economic considerations which underpin the safe and cost-effective use of biosimilar insulin therapy. Biosimilars are not the same as generic medications. Generic medication contains identical ingredients to the reference, whereas biosimilar medication is highly comparable but not necessarily identical to the reference. There are five biosimilar insulins currently available in Canada: insulin glargine (U-100) as the biosimilar insulins, Basaglar® and Semglee®, insulin lispro (U-100) as the biosimilar insulin, Admelog® and insulin aspart (U-100) as the biosimilar insulins, Trurapi® and Kirsty™. Data for biosimilars must be submitted in a stepwise approach to demonstrate similarity to the reference biologic under the following categories: structure & function, human clinical trials,..."

Journal • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus

Recognition of Need for Optimization of Diabetes Education for Children with Type 1 diabetes: Long term Provider Experience . (ENDO 2024) - "Case 2: The mother called at 9 pm and reported that by mistake, she did administer "Admelog" at 18 units instead of Basaglar, for her son, 11 year old with Type 1 diabetes. He was on Lantus and Humalog before... -Complications of Type 1 diabetes are preventable. The family needs further education on diabetes management including review of Insulin therapy when Insulin pump does malfunction, with a copy of written instruction of Insulin doses, differences in long and short acting Insulin along with psychosocial support to optimize care of children with Type 1 diabetes.Unless otherwise noted, all abstracts presented at ENDO must not be released to the press or the public until the date and time of presentation. For oral presentations, the abstracts are embargoed until the session begins."

Clinical • Diabetes • Hypoglycemia • Metabolic Disorders • Pediatrics • Type 1 Diabetes Mellitus

Afrezza® INHALE-1 Study in Pediatrics (clinicaltrials.gov) - P3 | N=319 | Active, not recruiting | Sponsor: Mannkind Corporation | Recruiting ➔ Active, not recruiting | Trial primary completion date: Feb 2024 ➔ Sep 2024

Combination therapy • Enrollment closed • Trial primary completion date • Diabetes • Metabolic Disorders • Pediatrics • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus

Afrezza® INHALE-1 Study in Pediatrics (clinicaltrials.gov) - P3 | N=264 | Recruiting | Sponsor: Mannkind Corporation | Trial completion date: Apr 2024 ➔ Apr 2025

Combination therapy • Trial completion date • Diabetes • Metabolic Disorders • Pediatrics • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus

A Case of Delayed Type Hypersensitivity Reaction to Insulin (ACAAI 2023) - "A prolonged desensitization protocol was initiated using subcutaneous insulin lispro and oral prednisone...She was transitioned to methotrexate as a steroid-sparing immunosuppressive agent. Discussion This case illustrates an extremely rare, delayed type, non-IgE mediated hypersensitivity to insulin that was initially managed using oral steroids and transitioned to a steroid-sparing immunosuppressive agent."

Clinical • Diabetes • Immunology • Metabolic Disorders • Pain • Type 1 Diabetes Mellitus

Progress towards the Replacement of the Rabbit Blood Sugar Test for the Quantitative Determination of the Biological Activity of Insulins (USP ) with an In Vitro Assay. (PubMed, Animals (Basel)) - "Thus, the in vitro ICW cell-based bioassay leads to results that are equivalent to the rabbit blood sugar test per USP , and it is highly suitable for insulin activity quantification. For future development compounds, the in vitro in-cell Western cell-based assay can replace the rabbit blood sugar test required by USP ."

Journal • Preclinical

Diabetic Ketoacidosis due to Non-Medical Switching (ENDO 2023) - "Both her standing prescription for long-acting (Basaglar, Eli Lilly and Company, Indianapolis, IN, USA) and rapid-acting (Admelog, sanofi-aventis U.S. LLC, Bridgewater, NJ, USA) insulin were no longer covered. The insulin treatment was switched as requested by her health insurance and Semglee (Mylan Pharmaceuticals Inc., a Viatris Company, Morgantown, WV, USA) as long-acting and Humalog (Eli Lilly and Company, Indianapolis, IN, USA) as rapid-acting insulin prescriptions were transmitted to the pharmacy electronically...Even if Admelog was prescribed, she was under the impression that she was getting her rapid-acting insulin needs from Semglee...Abstracts presented at a news conference are embargoed until the date and time of the news conference. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO.*"

Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Estimated Changes in Insulin Prices and Discounts After Entry of New Insulin Products, 2012-2019. (PubMed, JAMA Health Forum) - "Net prices of long-acting insulin products increased at an annual rate of 23.6% from 2012 to 2014 but decreased at an annual rate of 8.3% after the introduction of insulin glargine (Toujeo and Basaglar) and degludec (Tresiba) in 2015. Net prices of short-acting insulin increased at an annual rate of 5.6% from 2012 to 2017 but then decreased from 2018 to 2019 after the introduction of insulin aspart (Fiasp) and lispro (Admelog)...In this longitudinal study of US insulin products, results suggest that insulin prices substantially increased from 2012 to 2015, even after accounting for discounts. The introduction of new insulin products was followed by substantial discounting practices that lowered net prices faced by payers."

Journal

"Not doing anything with Admelog? 🤔🤔🤔@SanofiUS" (@MaryHartmanx2)

Similar Pharmacokinetics and Pharmacodynamics of Biosimilar SAR342434 Insulin Lispro and Japan-Approved Humalog Insulin Lispro in Healthy Japanese Subjects. (PubMed, Clin Pharmacol Drug Dev) - "SAR342434 and Humalog were well tolerated. In healthy Japanese males, SAR342434 and Humalog showed similar PK exposure profiles and PD potency, in support of SAR342434 use as a biosimilar product."

Clinical • Journal • PK/PD data

Afrezza® INHALE-1 Study in Pediatrics (clinicaltrials.gov) - P3; N=264; Recruiting; Sponsor: Mannkind Corporation; Not yet recruiting ➔ Recruiting

Clinical • Combination therapy • Enrollment open • Diabetes • Metabolic Disorders • Pediatrics • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus

Afrezza® INHALE-1 Study in Pediatrics (clinicaltrials.gov) - P3; N=264; Not yet recruiting; Sponsor: Mannkind Corporation; Trial completion date: Apr 2025 ➔ Apr 2024; Trial primary completion date: Apr 2024 ➔ Apr 2023

Clinical • Combination therapy • Trial completion date • Trial primary completion date • Diabetes • Metabolic Disorders • Pediatrics • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus

Afrezza® INHALE-1 Study in Pediatrics (clinicaltrials.gov) - P3; N=264; Not yet recruiting; Sponsor: Mannkind Corporation

New P3 trial • Diabetes • Metabolic Disorders • Pediatrics • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus

[VIRTUAL] Costs and Opportunities Related to the Short-Acting Insulin Analogues Adoption- A Budget IMPACT Analysis (ISPOR-EU 2020) - "OBJECTIVES Short-acting insulin analogues (aspart, lispro and glulisine) are widely used in diabetes management...The robustness of the results was demonstrated by the sensitivity analysis. CONCLUSIONS The results of the analysis highlight that a more appropriate use of short-acting insulin analogues can allow significant savings for the NHS, involving an optimization of the clinical and economic management of the therapy."

HEOR • Diabetes • Metabolic Disorders

Biosimilars and Novel Insulins. (PubMed, Am J Ther) - "Biosimilar insulins have comparable PK-PD profiles and equivalent efficacy and safety to original insulins at a lower price, making them available for more people with diabetes. Faster aspart is the first ultrafast-acting insulin. New upcoming clinical trials and more clinical experience with faster aspart will show the real potential of this new insulin."

Journal • Diabetes • Hypoglycemia • Metabolic Disorders • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus

Comparison of metabolic and mitogenic response in vitro of the rapid-acting insulin lispro product SAR342434, and US- and EU-approved Humalog®. (PubMed, Regul Toxicol Pharmacol) - "Statistical evaluation of the data demonstrated that the 90% CIs of the ratio of geometric means between SAR342434 and Humalog® EU or Humalog® US were within the predefined acceptance limits for each assay. Insulin lispro as SAR342434 solution demonstrated similarity to both US- and EU-approved Humalog® based on a side-by-side biological similarity assessment."

Journal • Preclinical

Assessment of the Safety of SAR342434 and Humalog® When Administered as Continuous Subcutaneous Insulin Infusion (clinicaltrials.gov) - P1; N=27; Completed; Sponsor: Sanofi; Recruiting ➔ Completed

Trial completion • Biosimilar • Diabetes

COMPARISON OF TWO PREGNANCIES OF A WOMAN WITH TYPE 1 DIABETES WITHOUT AND WITH AAPS (ANDROID ARTIFICIAL PANCREAS SYSTEM) SUPPORT (ATTD 2020) - "Methods A woman with 30 years of T1D underwent two subsequent pregnancies: Pregnancy one at age 35 using multiple daily injections (MDI) therapy (insulin glargine, Sanofi and insulin lispro, Eli-Lilly) with flash glucose monitoring (FGM; Abbott Libre Flash)...Conclusions AAPS in pregnant women with T1D can improve metabolic control at reduced risk of hypoglycaemia leading to substantially improved quality of life. Pregnant women with T1D are not willing to wait for commercially available closed loop systems."

Clinical

A Bioequivalence Study Comparing Two Different Strengths Formulations of Insulin Lispro in Patients With Type 1 Diabetes (clinicaltrials.gov) - P1; N=90; Completed; Sponsor: Sanofi; Active, not recruiting ➔ Completed

Clinical • Trial completion

A Bioequivalence Study Comparing Two Different Strenghts Formulations of Insulin Lispro in Patients With Type 1 Diabetes (clinicaltrials.gov) - P1; N=90; Active, not recruiting; Sponsor: Sanofi; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

Safety of Insulin Lispro and a Biosimilar Insulin Lispro When Administered Through an Insulin Pump. (PubMed, J Diabetes Sci Technol) - P1; "Both SAR-Lis and Ly-Lis were well tolerated by patients using insulin pumps. The results do not suggest a clinically significant difference in the risk of ISO between SAR-Lis and Ly-Lis when used in CSII."

Clinical • Journal

A Bioequivalence Study Comparing Two Different Strenghts Formulations of Insulin Lispro in Patients With Type 1 Diabetes (clinicaltrials.gov) - P1; N=90; Recruiting; Sponsor: Sanofi

Clinical • New P1 trial